Agreement and Diagnostic Performance of Urinary HPV Testing Versus Clinician-Collected Cervico-Vaginal Sampling: A Prospective Cross-Sectional Study in a Romanian Cohort
Nati et al.
The finding, in our words
Urinary HPV testing using first-void urine collected with the Colli-Pee device showed substantial agreement with clinician-collected cervico-vaginal sampling and near-equivalent negative predictive value, supporting its use as a clinically credible non-invasive entry point for cervical screening in settings where low participation rather than analytical performance is the principal barrier.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
First-void urine samples showed significantly higher detection rates of HPV-specific IgG antibodies compared to midstream urine, confirming the necessity of capturing the initial stream. The study found no significant difference between 10 mL and 20 mL collection volumes, indicating flexibility in device specifications for self-collection.
Van Caesbroeck et al., Human vaccines & immunotherapeutics · source ↗
This meta-analysis found that self-collected urine samples for HPV testing had lower sensitivity for detecting high-grade lesions compared to physician-collected cervical specimens. The use of a first-void collection device such as Colli-Pee was associated with marginally higher sensitivity than general urine sampling.
Chen et al., Journal of lower genital tract disease (paywalled) · source ↗
This randomised sub-study found return rates of 10.4% for Colli-Pee, 10.1% for FLOQSwabs and 7.4% for Evalyn-Brush. All devices yielded sufficient DNA with low invalid rates, but the authors noted the study was limited by low overall participation.
Hempel et al., Archives of gynecology and obstetrics · source ↗
For decentralised testing, a study found dry vaginal self-samples using Copan FLOQSwabs stored up to two weeks at room temperature maintain DNA quality. However, first-void urine collected with the Colli-Pee device may be less sensitive for HPV detection, showing lower positivity and higher cycle threshold values, median Ct 30 versus 27 for other samples.
Chu et al., BJOG : an international journal of obstetrics and gynaecology · source ↗
In 498 women living with HIV, self-collected first-void urine and vaginal samples showed 78% high-risk HPV prevalence and good genotype concordance, kappa 0.64-0.78. Participants preferred the Colli-Pee device over the Evalyn Brush, supporting decentralised, patient-centric screening feasibility.
Madsen et al., Journal of medical virology · source ↗